NCT01823367|Completed
Encourage Healthy Families
Encourage
Primary Prevention of Diabetes in Children and Mothers at Increased Risk: Encourage Healthy Families.
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Encourage
Primary Prevention of Diabetes in Children and Mothers at Increased Risk: Encourage Healthy Families.
Sponsor study identifier
interventional
335
1 country
1
Study Start
December 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 27, 2016
Actual (reported)Study Completion
April 27, 2016
Actual (reported)This study is a randomized intervention that will test two different approaches reflecting diverse levels of both intensity and cost, to achieving risk reduction of T2D. This will help address a critical question in the translation of primary prevention research into the public health: how much intensity (and thus cost) is required to achieve an effective outcome? In addition, the proposed study will address a critical need in diabetes prevention that has not received sufficient scholarly attention: the prevention of T2D in children. No studies of diabetes prevention similar in scope to the DPP have been performed in school-aged children; however, reducing childhood obesity is widely accepted as the primary pathway to decreasing the growing prevalence of T2D in the pediatric population.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 27, 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2012
Date type not reportedThis date has not been verified as actual or estimated.
March 27, 2013
Actual (reported)April 4, 2013
Actual (reported)April 27, 2016
Actual (reported)April 27, 2016
Actual (reported)Changes in weight
Weight taken during data collection visits
3, 6, and 12 months after the beginning of the assigned intervention program
Changes in diet
3, 6, and 12 months after the beginning of the assigned intervention program
This intervention, delivered to groups of mothers only, builds upon the evidence-based curriculum used in the Diabetes Prevention Program (DPP) and incorporates into the curriculum detailed education regarding ways to help their children adopt healthier lifestyle behaviors.
The second intervention is delivered to both mothers and children in separate groups using the same parent Diabetes Prevention Program (DPP) curriculum, but adds a group program for children that directly teach these children strategies for eating better and increasing physical activity.
Diabetes Prevention Program (DPP): This is an evidence-based curriculum that has shown that it is possible to prevent or delay Type 2 Diabetes (T2D) in individuals if they keep a healthy weight, eat a nutritious diet, and stay physically active.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Palmer KNB, Garr Barry VE, Marrero DG, McKinney BM, Graves AN, Winters CK, Hannon TS. Intervention Delivery Matters: What Mothers at High Risk for Type 2 Diabetes Want in a Diabetes Prevention Program-Results from a Comparative Effectiveness Trial. Diabetes Ther. 2020 Oct;11(10):2411-2418. doi: 10.1007/s13300-020-00891-1. Epub 2020 Aug 8.
Hannon TS, Carroll AE, Palmer KN, Saha C, Childers WK, Marrero DG. Rationale and design of a comparative effectiveness trial to prevent type 2 diabetes in mothers and children: the ENCOURAGE healthy families study. Contemp Clin Trials. 2015 Jan;40:105-11. doi: 10.1016/j.cct.2014.11.016. Epub 2014 Nov 29.
David G Marrero, PhD.
Inidana University School of Medicine
335 participants (actual enrollment reported by the registry).
First Submitted
March 27, 2013
First Posted
April 4, 2013
Study Start
December 2012
Date type not reportedThis date has not been verified as actual or estimated.
Integrating Cultural Aspects Into Diabetes Education
Contact the study team to confirm eligibility.
Primary Completion
April 27, 2016
Actual (reported)Study Completion
April 27, 2016
Actual (reported)Last Updated
August 25, 2017
Record last verified: 2017-08
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Source: ClinicalTrials.gov.
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